Validity of a Wearable Digital Insole for Assessing Gait ON and OFF in Parkinson’s Disease

Objective Gait impairment is a distinctive symptom of Parkinson's disease that negatively impacts mobility. We assessed the validity of wearable digital insoles against a validated reference gait analysis system for measuring select gait characteristics in patients with Parkinson's disease. Methods A comparative analysis between digital insoles (Moticon ReGo Insole) and the GAITRite system was conducted in patients with Parkinson's disease. Patients were assessed in both the OFF and ON medication states. Gait characteristics were measured simultaneously with both systems during two 10m walk tests. Patients also completed a patient experience survey following the use of the digital insoles. Results Overall, 21 patients with Parkinson's disease were included in the study. Analytical validation for gait cadence, speed, and stride length showed excellent agreement (intraclass correlation coefficients between 0.93-0.97) in both the OFF and ON states. Stance, swing, and double support times exhibited lower validity with moderate agreement (intraclass correlation coefficients from 0.48-0.57). Gait speed and stride length were significantly associated with scores on the Movement Disorders Society's Unified Parkinson's Disease Rating Scale (p=0.0085 and 0.013, respectively). Mean differences in all parameters measured with the insoles, except cadence, were significantly different between OFF and ON states (p<0.003). The majority of patients liked wearing the digital insoles and found them comfortable and user-friendly. Interpretation These findings support the validity of Moticon ReGo digital insoles for the assessment of several important gait characteristics in Parkinson's disease.